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IOPS™ Software Application

Centerline Biomedical, Inc. · Model SW-1 · UDI-DI 00843152104000

DQK Prescription

510(k) clearances

4,492

Adverse events (53 deaths)

125

Recalls

179

Facilities

Description

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Recalls

Date	Firm	Reason
2026-07-30	GE Medical Systems Information Technologies Inc	Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
2026-04-24	GE Medical Systems Information Technologies Inc	Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charr
2025-09-16	Spacelabs Healthcare, Ltd.	Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm
2025-08-11	Merge Healthcare, Inc.	Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes
2025-04-11	Centerline Biomedical Inc	Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.